MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2015-05-20 for DEKNATEL DEK BL MF 0 TC-43 2N 48 833-123 manufactured by Teleflex Medical.
[17693189]
Complaint alleges that during a sacrospinous vault suspension procedure the capio suture head broke off in the capio slim device, and got caught in the lower trac where the suture is received. Failure happened inside pt. Another capio suture was used to complete the procedure. No pt injury reported. Pt current condition reported, as fine.
Patient Sequence No: 1, Text Type: D, B5
[17735620]
(b)(4). Device history record (dhr) investigation did not show issues related to this complaint. No corrective action can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect. At this time, due to the lack of defective product, it is not possible to confirm the complaint and to determine the root cause. The mfr will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
[28914678]
(b)(4). One unit of catalog number 833-123 was received for analysis. A visual inspection was performed, sample sent was not received in its original packaging, since carrier and pouch is missing. Sample received had 1 bullet attached to the suture, however, the current configuration for this product requires a bullet attached to both ends , which means 2 bullets per suture. Tensile strength test was performed on the attachments as per (b)(4). The sample withstands the required specifications. Customer complaint is confirmed based on the condition identified on the sample received (without bullet attached on 1 end) however, it is uncertain what caused the bullet detachment since the testing performed met the specification.
Patient Sequence No: 1, Text Type: N, H10
[28914679]
Complaint alleges that during a sacrospinous vault suspension procedure, the capio suture head broke off in the capio slim device , and got caught in the lower trac where the suture is received. Failure happened inside patient. Another capio suture was used to complete the procedure. No patient injury reported. Patient current condition reported, as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00149 |
| MDR Report Key | 4788191 |
| Report Source | 01,06,07 |
| Date Received | 2015-05-20 |
| Date of Report | 2015-05-05 |
| Date of Event | 2015-04-20 |
| Date Mfgr Received | 2015-10-16 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-06-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEKNATEL DEK BL MF 0 TC-43 2N 48 |
| Generic Name | CAPIO SUTURE |
| Product Code | MFJ |
| Date Received | 2015-05-20 |
| Returned To Mfg | 2015-09-15 |
| Catalog Number | 833-123 |
| Lot Number | 74D1400172 |
| Device Expiration Date | 2019-04-30 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-20 |